Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients

Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism (VTE) After Abdominal Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00333021

Enrollment

127

Registered

2006-06-02

Start date

2006-05-31

Completion date

2007-02-28

Last updated

2009-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Keywords

Fondaparinux Abdominal surgery Japanese VTE

Brief summary

This study is phase 3 study for prevention of VTE in patients with abdominal surgery.

Interventions

DRUGFondaparinux sodium

DRUGGSK576428

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged \>=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes. * General or urologic surgery * Cancer surgery * Gynecologic surgery * Radical surgery for pelvic malignancy

Exclusion criteria

* Active, clinically significant bleeding Thrombocytopenia Body weight \<40kg

Design outcomes

Primary

Measure	Time frame
Incidence of Venous thromboembolism and Major bleeding	Throughout entire study

Secondary

Measure	Time frame
Incidence of Pulmonary embolism Incidence of Deep vein thrombosis Incidence of symptomatic Venous thromboembolism	Throughout entire study

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026